BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3080149 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00994
    Event Type
    Injury
    Date Received
    April 26, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH CAPTURE THRESHOLD WAS OBSERVED. LEAD DISLODGEMENT WAS NOTED. LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182927 DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7172Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention